A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder

PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Post Traumatic Stress Disorder (PTSD)
Interventions
PROCEDURE

Stellate Ganglion Block injection with ropivicane

For participants receiving the stellate ganglion injection with ropivicaine, a 22 g needle will be directed percutaneously to the anterolateral C6 vertebral body Using ultrasound guidance to avoid the nearby vascular structures and identify the appropriate vertebral level and tissue plane. After negative aspiration for blood and CSF, and digital subtraction, 2cc of Iohexol,(Omnipaque 180) will be injected through the needle under live fluoroscopy to visualize dye spread over the pre-vertebral plane At this point, 7 cc 0.5% ropivicaine will be injected and the needle will be removed.

PROCEDURE

Placebo Procedure

In participants randomized to the placebo injection, the same positioning, monitoring, sterile preparation and technique and local anesthesia protocol will be used. The 22 g needle will instead be placed in the subcutaneous, superficial tissues overlying the C6 tubercle, but superficial enough that the prevertebral fascial plane of the stellate ganglion will not be breached. Using fluoroscopic guidance, this needle will be injected with 2 cc of contrast dye to confirm superficial spread. The needle will then be injected with 5 cc of preservative free normal saline and the needle will be removed.

Trial Locations (1)

92134-1005

United States Naval Medical Center San Diego, San Diego

All Listed Sponsors
lead

United States Naval Medical Center, San Diego

FED

NCT01629537 - A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder | Biotech Hunter | Biotech Hunter